Be Prepared and Know the FDA’s Expectations Regarding Immunogenicity Testing – Lessons Learned

Bioanalysis and Immunogenicity Webinar Series. Register now for this webinar that will run on Wed 23 May 2018 at 16:00 BST / 08:00 PDT

The FDA released an update to the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins in April 2016. This webinar will outline how the April 2016 draft document is being used in FDA inspections and the FDA expectations for immunogenicity testing. Specific testing parameters and acceptance criteria will be discussed in depth in addition to 483 issued in the field of immunogenicity and what they mean.

What will you learn?

  • How the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins is being implemented
  • Expectations by the FDA for immunogenicity testing and interpretation in the draft guidance
  • 483 observations recently issued and what they mean

Please complete the form below to register.